Type 1 Diabetes Clinical Trial
Official title:
The Role of Exenatide in Type 1 Diabetes Mellitus
NCT number | NCT00456300 |
Other study ID # | H-16488 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | March 2007 |
Est. completion date | March 2009 |
Verified date | February 2019 |
Source | Montefiore Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to see if giving exenatide and insulin before a meal would lower blood sugars after the meal. This study may help in developing new treatments to help control high blood sugars after meals. This may help improve overall blood sugar control and prevent the long-term effects of diabetes.
Status | Completed |
Enrollment | 11 |
Est. completion date | March 2009 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 21 Years |
Eligibility |
Inclusion Criteria: ***Subjects must be patients of the Texas Children's Hospital Diabetes Care Center***. All of the following criteria must be met: 1. Between 12-21 years of age at the time of enrollment. 2. Have been diagnosed with Type 1 diabetes for at least 1 year and in good control (HbA1C less than 8.5%). 3. Subjects must be otherwise healthy except for the Type 1 Diabetes and treated hypothyroidism. 4. Menstruating women must have a negative pregnancy test. 5. Hemoglobin equal to or greater than 12 g/dL before each study. 6. Weight greater than 44 kg. 7. Tanner stage greater than 3 Exclusion Criteria: 1. Any chronic disease: leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis etc or on treatment that might directly or indirectly affect glucose homeostasis, except for diabetes and hypothyroidism; stable on medications. 2. Lack of a supportive family environment as detected by the clinicians and/or social workers. 3. Positive pregnancy test in menstruating young women. 4. BMI greater than 90th percentile for age or less than 10th percentile for age. 5. Lactating and nursing mothers. |
Country | Name | City | State |
---|---|---|---|
United States | Texas Children's Hospital/ Baylor College of Medicine | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Montefiore Medical Center | National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Plasma Glucose Area Under the Curve (AUC) for Blood Glucose Concentration in the Exenatide 1.25 mcg or Exenatide 2.5 mcg Treated Groups Along With Insulin, Compared to Insulin Alone | Post-prandial blood glucose concentration in terms of mean AUC (0-120 min) was determined in subjects treated with either Exenatide 1.25 mcg or Exenatide 2.5 along with insulin, compared to insulin alone, given as a single subcutaneous injection | 0-120 minutes post-dose |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05653518 -
Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes
|
N/A | |
Enrolling by invitation |
NCT05515939 -
Evaluating the InPen in Pediatric Type 1 Diabetes
|
||
Completed |
NCT05109520 -
Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL
|
||
Recruiting |
NCT04016987 -
Automated Structured Education Based on an App and AI in Chinese Patients With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT04190368 -
Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents and Young Adults With Type 1 Diabetes
|
N/A | |
Recruiting |
NCT05413005 -
Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Type 1 Diabetes Mellitus
|
Early Phase 1 | |
Active, not recruiting |
NCT04668612 -
Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes
|
N/A | |
Completed |
NCT02837094 -
Enhanced Epidermal Antigen Specific Immunotherapy Trial -1
|
Phase 1 | |
Recruiting |
NCT05414409 -
The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action
|
Phase 2 | |
Recruiting |
NCT05670366 -
The Integration of Physical Activity Into the Clinical Decision Process of People With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT05418699 -
Real-life Data From Diabetic Patients on Closed-loop Pumps
|
||
Completed |
NCT04084171 -
Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6
|
N/A | |
Recruiting |
NCT06144554 -
Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
|
||
Recruiting |
NCT05153070 -
Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes
|
Phase 2 | |
Recruiting |
NCT05379686 -
Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes
|
N/A | |
Completed |
NCT05281614 -
Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D
|
Early Phase 1 | |
Withdrawn |
NCT04259775 -
Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT01600924 -
Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes
|
||
Completed |
NCT02914886 -
Beneficial Effect of Insulin Glulisine by Lipoatrophy and Type 1 Diabetes (LAS)
|
Phase 4 | |
Completed |
NCT02897557 -
Insulet Artificial Pancreas Early Feasibility Study
|
N/A |